Services Medical Devices Certification and Approval
Marketing of a device can require compliance to a number of different regulations and standards. DLRC are able to help with marketing to any jurisdiction as requested by the client.
DLRC are able to take Quality Management System documentation or Technical Documentation and analyse to any regulation or standard as determined by the client. DLRC will provide a report which includes Gaps and the options for remediation.
After entering into force on May 25, 2017, the European Union (EU) Medical Device Regulation (MDR) EU 2017/745 will be applied to all Member States from May 26, 2021, after a one-year extension. Since Brexit, the UKCA mark is also mandatory for all devices sold into the UK. The strategy for the upgrade of the technical documentation to compliance with the EU MDR 2017/745 will depend on the device type, design and history as well as the current State of the Art for device use. DLRC are able to offer expert transition plans to accommodate each device type and Manufacturer to ensure compliance to the Regulations.
The corresponding date of application of the In Vitro Diagnostic Medical Devices Regulation (IVDR, Regulation (EU) 2017/746) remains in May 2022. Since Brexit, the UKCA mark is also mandatory for all in vitro diagnostic devices sold into the UK. The strategy for the upgrade of the technical documentation to compliance with the EU IVDR 2017/746 will depend on the device type, design and history as well as the current State of the Art for device use. DLRC are able to offer expert transition plans to accommodate each device type and Manufacturer to ensure compliance to the Regulations.
Engagement and relationship building with a Notified Body is a key factor in the ease to which market authorisation can be effectively achieved. DLRC have years of experience selecting and engaging with Notified Bodies. DLRC are able to assist with the most appropriate Notified Body or UK Approved Body selection for each organisation and ensure the engagement and approval process are suitable for the Manufacturer.
Device technical file documentation creation is a fundamental element of any device certification and the continued compliance of the device to the Regulations. DLRC is able to create the technical documentation for any device to ensure market device certification can be achieved.
Risk Management and Usability Engineering files are key elements to any device design and technical file, and, in accordance with the relative standards, DLRC are able to compile these files to ensure the compliance for the device.
Clinical Evaluation and Performance Evaluation Plans and Reports are key to the requirements of the regulations and must be fully established for device certification and updated throughout the lifecycle of the device. DLRC are able to establish these documents for all devices in accordance with the Regulations.
DLRC can assist with all engagement with the FDA regarding market clearance and approval in the USA, this includes the pre-market submission process also.
510(k), De Novo, PMA, IDE (USA)
DLRC can complete all requirements for the market clearance and approval of the device in accordance with any submission process most suited to the device.
